RECKITT BENCKISER LLC v. AMNEAL PHARMACEUTICALS LLC

Filing 214

REDACTED OPINION FILED. Signed by Judge Renee Marie Bumb on 8/22/17. (js)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
CAMDEN VICINAGE

RECKITT BENCKISER LLC,
Plaintiff,

Civil No. 15-2155 (RMB/JS)
v.

AMNEAL PHARMACEUTICALS LLC, et
al.,
Defendants.
RECKITT BENCKISER LLC,
Plaintiff,

Civil No. 15-4524 (RMB/JS)
OPINION
(PUBLIC)

v.
DR. REDDYS LABORATORIES, LTD.,
et al.,
Defendants.

Plaintiff Reckitt Benckiser LLC (“Reckitt” or “Plaintiff”)
brings this Hatch-Waxman action for patent infringement against
Defendants Amneal Pharmaceuticals LLC (“Amneal”) and Dr. Reddy’s
Laboratories, Inc. (“DRL”) (collectively, “Defendants”) pursuant
to 35 U.S.C. § 271(e)(2)(A) and §§ 271(a), (b), and (c).
I.

Reckitt’s Guaifenesin Drug Mucinex® and the Patents-in-Suit
This case involves Reckitt’s Mucinex® product, an extended-

release guaifenesin tablet used as an expectorant that thins and
loosens mucus and relieves chest congestion.

Reckitt initially

alleged that Amneal’s generic 600 mg and 1200 mg guaifenesin
sustained-release tablets (“Amneal’s ANDA products”) will

1

infringe U.S. Patent Nos. 6,372,252 (the “’252 Patent”),
6,955,821 (the “’821
Patent”).

Patent”), and 7,838,032 (the “’032

Similarly, Reckitt initially alleged that DRL’s

generic 600 mg and 1200 mg guaifenesin and pseudoephedrine
hydrochloride sustained-release tablets (“DRL’s ANDA Products”)
will infringe the ’252, ’821, and ’032 Patents.

After the

filing of the Complaints, Reckitt dismissed its claims under the
’252 Patent as to both Defendants [Docket Nos. 64, 65] and its
claims under the ’821 Patent against Defendant DRL [Docket No.
64]. 1
At the heart of the dispute is whether Defendants’ ANDA
Products have two distinct formulations, an immediate release
formulation (“IR formulation”) and a sustained release
formulation (“SR formulation”).

Reckitt contends that they do.

Defendants counter that their ANDA products are single
formulation matrix tablets and therefore do not infringe the
Patents-in-Suit.
A.

The ’821 Patent

The ’821 Patent is entitled “Sustained Release Formulations
of Guaifenesin and Additional Drug Ingredients” and is a
continuation-in-part of the ’252 Patent.
(“SF”) [Docket No. 157] ¶ 8-9.

Stipulated Facts

The named inventors are Robert

1

The Defendants also dismissed their respective Counterclaims
and Affirmative Defenses.
2

D. Davis, Ralph W. Blume, and Donald Jeffery Keyser.

SF ¶ 10.

The ’821 Patent was filed on April 15, 2002, as Application No.
10/121,706.
¶ 11.

The ’821 Patent expires on April 28, 2020.

SF

Reckitt is the owner and current assignee of the ’821

Patent.

SF ¶ 12.

Claims 30, 35, 36, 41, and 70 of the ’821 Patent are
asserted against Defendant Amneal only.

SF ¶ 20.

Amneal has

stipulated that its ANDA products satisfy every limitation of
the asserted claims of the ’821 Patent except for the elements:
“modified release drug product;” “first quantity of guaifenesin
in an immediate release formulation;” and “second quantity of
guaifenesin in a sustained release form/release-delaying
matrix.”
B.

SF ¶ 24.
The ’032 Patent

The ’032 Patent is entitled “Sustained Release of
Guaifenesin” and is a continuation-in-part of the ’821 Patent,
which is a continuation-in-part of the ’252 Patent.

SF ¶ 14-15.

The named inventors are Robert D. Davis, Ralph W. Blume, and
Donald Jeffery Keyser.

SF ¶ 16.

The ’032 Patent was filed on

April 4, 2003 as Application No. 10/406,557.
expires on April 28, 2020.

SF ¶ 17.

The ’032 Patent

current assignee of the ’032 Patent.

Reckitt is the owner and
SF ¶ 18.

Claims 1, 2, 5, and 6 of the ’032 Patent are asserted
against both DRL and Amneal.

SF ¶ 25.
3

DRL and Amneal have

stipulated that their respective 1200 mg ANDA products satisfy
every limitation of claims 1 and 2 except for the following
claim elements directed to the drug product “having two
portions” of guaifenesin: “a first portion comprises guaifenesin
in an immediate release form;” and “a second portion comprises
guaifenesin in a sustained release form.”

SF ¶ 27.

DRL and

Amneal have also stipulated that their respective 600 mg ANDA
products satisfy every limitation of claims 5 and 6 except for
the following claim elements directed to the drug product
“having two portions” of guaifenesin: “a first portion comprises
guaifenesin in an immediate release form;” and “a second portion
comprises guaifenesin in a sustained release form.”
C.

SF ¶ 28.

Mucinex®

The FDA approved NDA No. 21-282 in July 2002 for 1200 mg
guaifenesin extended-release tablets and in December 2002 for
600 mg guaifenesin extended-release tablets, both of which are
marketed by Reckitt under the trademark Mucinex®.
Mucinex® is approved for use as an expectorant.

SF ¶ 29-30.
SF ¶ 30.

The

FDA approved NDA No. 21-585 in June 2004 for 600 mg/60 mg and
1200 mg/120 mg guaifenesin and pseudoephedrine hydrochloride
extended-release tablets, which are marketed by Reckitt under
the trademark Mucinex® D.

SF ¶ 31-32.

Mucinex® D is approved

for use as an expectorant and nasal decongestant.

4

SF ¶ 32.

The claims asserted by Reckitt cover both Mucinex® SE and
Mucinex® D.

Mucinex® SE products contain guaifenesin as the

only active pharmaceutical ingredient (“API”) and Mucinex® D
products contain both guaifenesin and pseudoephedrine as the two
APIs.

SF ¶ 33, 35.

Both of Reckitt’s Mucinex® products are bi-layer tablets,
one layer containing guaifenesin in an IR form that provides
fast-acting relief, and the other layer containing guaifenesin
in a SR form that continues to release guaifenesin for 12 hours.
SF ¶ 37.

Mucinex® is a preferred example of and is disclosed as

Formulation IV in the Patents-it-Suit. 2

Tr. 101:14-102:2; 652:1-

6; Tr. 829:22-23.
D.

Amneal’s ANDA and ANDA Product

Amneal filed an Abbreviated New Drug Application (“ANDA”)
No. 207342 with the FDA seeking regulatory approval to market
guaifenesin extended-release tablets in 1200 mg and 600 mg
dosages.

SF ¶ 38-39.

Amneal’s ANDA identifies the listed drug

product that is the basis for the submission as Mucinex®.
45.

SF ¶

Amneal’s ANDA included a paragraph IV certification

asserting that the ’252, ’821, and ’032 Patents are invalid,
unenforceable, or will not be infringed by the manufacture or

2

“Tr.” refers to the transcript of the trial conducted by the
Court on May 15-18.
5

E.

DRL’s ANDA and ANDA Product

DRL filed ANDA No. 208369 with the FDA seeking regulatory
approval to market guaifenesin extended-release tablets.
46-47.

SF ¶

DRL’s ANDA identifies the listed drug product that is

the basis for the submission as Mucinex®.

SF ¶ 52.

DRL’s ANDA

included a paragraph IV certification asserting that the ’252,
’821, and ’032 Patents are invalid, unenforceable, or will not
be infringed by the manufacture or sale of its generic extendedrelease guaifenesin tablets.

SF ¶ 51.

DRL’s ANDA is currently

pending.
As with Amneal, there is no dispute that DRL intended to
develop generic products that are therapeutically equivalent to
Mucinex® D, nor any dispute that DRL has concluded that its
products have comparable dissolution profiles to, and are
bioequivalent with, Mucinex® SE products.

SF ¶ 66-68.

The

parties have also stipulated that DRL’s ANDA products have the
following composition:

7

II.

Procedural History Before This Court
On August 14, 2015, and September 25, 2015, Amneal and DRL

each filed motions for judgment on the pleadings under Rule
12(c) arguing that their ANDA products do not infringe the
Patents-in-Suit because their products are single-formulation
matrix tablets that were disclaimed during the prosecution of
the ’252 Patent.

On January 15, 2016, the Court denied the

motions on the ground that Reckitt should be afforded limited
discovery regarding the actual structure of the Defendants’ ANDA
products. 3
On May 11, 2016, Defendants, contending their products were
single formulation release tablets, filed a summary judgment
motion of non-infringement.

They argued that the disclaimer of

single formulation sustained release tablets that Reckitt had
made during the prosecution of the ’252 Patent should also apply
to the ’821 and ’032 Patents.

On December 22, 2016, the Court

denied the motions, without opinion, and thereafter scheduled a
trial on the merits. 4
On March 28, 2017, the Court issued an Order adopting the
claim constructions of Judge Stark set forth in Reckitt

3

The Court also consolidated the cases under Case No. 15-2155.
[Docket No. 47].
4

As discussed infra, the parties dispute that the Defendants’
ANDA products are single-formulation release tablets.
8

Benckiser LLC v. Aurobindo Pharma Ltd., C.A. No. 14-1203-LPS,
2016 U.S. Dist. LEXIS 152337 (D. Del. Nov. 3, 2016) (“Aurobindo
I”) and Reckitt Benckiser LLC v. Aurobindo Pharma Ltd., C.A. No.
14-1203-LPS, 2017 U.S. Dist. LEXIS 31985 (D. Del. Mar. 6, 2017)
(“Aurobindo II”), appeal docketed, No. 17-1895 (3d Cir. Apr. 12,
2017).

[Docket No. 127].

The Court set the matter down for

trial, limiting the trial to the issue of infringement only.
III. Prior Related Litigation
The case that comes before this Court is not Reckitt’s
first challenge against a manufacturer of a generic Mucinex®.
Three other courts have found no infringement by three other
manufacturers of generic single formulation matrix tablets.
Reckitt contends that Defendants’ reliance on prior litigation
is misplaced because the prior cases involve a different patent
(the ’252 Patent), different claim construction, and different
products.

The Court disagrees, in part.

While it is true that

the ’252 Patent is no longer part of this case, Defendants’
products must have a discrete IR formulation and SR formulation
to infringe.

Reckitt has rehashed some of its earlier arguments

and the prior courts’ discussions of those arguments are
instructive.

Moreover, whether or not Reckitt adequately

addressed the deficiency of proof identified by the Aurobindo
court (infra) requires analysis of that court’s decision whose
claim construction this Court has adopted.
9

A.

Watson Litigation

On April 24, 2009, Reckitt filed an infringement lawsuit
against Watson Laboratories, Inc. – Florida and Watson
Pharmaceuticals, Inc. (“Watson”) for infringement of the ’252
and ’821 Patents, subsequently dismissing the ’821 Patent claim.
Plaintiff’s Responses to Defendants’ Proposed Findings of Fact
(“PRDFF”), ¶ 12 (citing Reckitt Benckiser, Inc. v. Watson
Laboratories, Inc. Florida, Case No. 09-60609 (S.D. Fla. 2009)). 5
The District Court held that Watson did not infringe the ’252
Patent, either literally or under the doctrine of equivalents.
Reckitt Benckiser, Inc. v. Watson Laboratories, Inc. Florida,
Case No. 09-60609, 2011 U.S. Dist. LEXIS 83090, ¶ 238 (S.D. Fla.
Feb. 18, 2011). In relevant part, that Court found that Watson’s
products were prepared from a single uniform blend.
143.

Id. at ¶

Moreover, the Court found that the “guaifenesin granules

that touch the surface are not part of a separate structure from
the balance of the guaifenesin and the other ingredients; all
are part of a single structure. Watson’s ANDA products do not
have two structural portions.”

Id. at ¶ 204.

On July 7, 2011,

the Court of Appeals for the Federal Circuit affirmed the

5

As will be discussed below, the “portion” containing limitation
language in the '252 Patent at issue in Watson and Perrigo,
infra, is nearly identical to the language in the Patents-inSuit.
10

District Court’s judgment of non-infringement, holding that
“[t]he district court correctly concluded that Watson’s products
do not have two structural portions and that guaifenesin
granules on the surface of Watson’s tablets do not constitute
the claimed first portion of guaifenesin in an IR form.”
Reckitt Benckiser Inc. v. Watson Laboratories, Inc., Florida,
430 Fed. Appx. 871, 877 (Fed. Cir. 2011).
B.

Perrigo Litigation

In 2007, Adams Respiratory Therapeutics, Inc., Reckitt’s
predecessor-in-interest, and related entities filed an
infringement lawsuit against Perrigo Company (“Perrigo”) and
related entities for infringement of the ’252 Patent.

Adams

Respiratory Therapeutics, Inc. et al v. Perrigo Co., Case No.
1:07-CV-993 (W.D. Mich. 2007).

The Perrigo District Court

granted summary judgment of non-infringement.

In relevant part

the Court held that “[i]n spite of its attempts to distinguish
Watson, [Reckitt] made substantially the same argument to the
Federal Circuit in Watson (including that the Guaifenesin on the
surface of Watson’s tablets was uninhibited by polymer) that it
now makes in this case with regard to Perrigo’s tablet.”
Perrigo, Case No. 1:07-CV-993, 2012 U.S. Dist. LEXIS 3288, at
*16 (W.D. Mich. Jan. 11, 2012).

In short, the Court held that

Perrigo, like Watson, made a single formulation tablet which was
disclaimed in the ’252 Patent.
11

C.

Aurobindo Litigation

On September 14, 2014, Reckitt filed an infringement suit
against Aurobindo Pharma Ltd. (“Aurobindo”) for infringement of
the ’821, ’032 and ’252 Patents, later dismissing the ’252
Patent from its suit.

See generally Aurobindo I, 2016 U.S.

Dist. LEXIS 152337 and Aurobindo II, 2017 U.S. Dist. LEXIS
31985.

The Court found that the asserted claims of the ’821 and

’032 Patents require “two distinct formulations.” See Aurobindo
I, 2016 U.S. Dist. LEXIS 152337, at *6-8.

The Court then

granted summary judgment of non-infringement concluding that “a
reasonable factfinder could only conclude that Aurobindo seeks
FDA approval of a single-formulation, extended-release product.”
Aurobindo II, 2017 U.S. Dist. LEXIS 31985, at *15.

(The

Aurobindo decisions will be discussed in greater detail infra.)
IV.

Trial Before This Court
Trial on the issue of infringement commenced on May 15,

2017, and lasted four days.
June 29, 2017.

Closing arguments were heard on

Defendants’ invalidity claims were stayed

pending the outcome of the infringement trial.

Reckitt

presented the testimony of Dr. Martyn C. Davies, a professor of
biomedical surface chemistry at the University of Nottingham
School of Pharmacy. 6

In general, relying on his Raman analyses,

6

Without objection, Dr. Davies was offered by Reckitt as an
expert in “the fields of formulation, structural analysis and
12

Dr. Davies opined that Defendants’ ANDA Products have two
distinct formulations of guaifenesin, an IR formulation without
rate-controlling polymers on the surface and a SR formulation
including rate-controlling polymers in the interior.
Defendants presented five experts at trial.

Dr. Harry

Brittain and Dr. Richard Gemeinhart, two experts in
pharmaceutical formulation, generally testified that Defendants’
ANDA products are matrix tablets made from a single uniformly
distributed blend of ingredients. 7

Two experts, Dr. Robin Rogers

and Dr. Neil Spingarn, generally testified about the flaws and
weaknesses of Dr. Davies’s Raman analyses. 8

Finally, Dr. Jeffrey

Rodriguez, a computer imaging expert called by DRL testified

characterization and performance of controlled release
pharmaceutical dosage forms.” Tr. 97:25-98:6.
7

Without objection, Dr. Brittain was offered by DRL as an expert
in “pharmaceutical formulations and characterization, including
with respect to sustained-release formulations.” Tr. 537:1-4.
Without objection, Dr. Gemeinhart was offered by Amneal as an
expert in “controlled drug delivery systems and dosage forms and
the materials used in those systems and dosage forms.” Tr.
698:17-23.
8

Without objection, Dr. Rogers was offered by Amneal as an
expert in “solid state chemistry and the characterization of
solid state materials and pharmaceutical formulations.” Tr.
895:4-8. Without objection, Dr. Spingarn was offered by DRL as
an expert in “Raman spectroscopy and its use in analysis of
pharmaceutical formulations.” Tr. 981:17-21.
13

about his count of the guaifenesin and

pixels in Dr.

Davies’s Raman maps. 9
After considering all the evidence, and the parties’
submissions, for the reasons set forth herein, the Court finds
that Amneal and DRL will not infringe the ’032 and ’821
Patents.

The Court declines to exercise jurisdiction over the

counterclaims asserting invalidity.

This Opinion constitutes

the Court’s findings of fact and conclusions of law pursuant to
Federal Rule of Civil Procedure 52(a).
V.

Literal Infringement
To prove infringement, the patentee must show that it is

more likely than not that the proposed ANDA product would, if
commercially marketed, meet all of the claim limitations of the
Patents-in-Suit.

See Adams Respiratory Therapeutics, Inc. v.

Perrigo Co., 616 F.3d 1283, 1289 (Fed. Cir. 2010); Abbott Labs.
v. TorPharm, Inc., 300 F.3d 1367, 1373 (Fed. Cir. 2002)
(infringement analysis turns on whether accused product
satisfies every limitation of the claim in question); Laitram
Corp. v. Rexnord, Inc., 939 F.2d 1533, 1535 (Fed. Cir. 1991)
(“To establish infringement, every limitation set forth in a
patent claim must be found in an accused product . . . .”).
other words, the patentee “has the burden of proving

9

Without objection, Dr. Rodriguez was called as an expert in
“image processing and analysis.” Tr. 1080:17-20.
14

In

infringement by a preponderance of the evidence.”

Kegel Co.,

Inc. v. AMF Bowling, Inc., 127 F.3d 1420, 1425 (Fed. Cir. 1997);
SmithKline Diagnostics, Inc. v. Helena Labs. Corp., 859 F.2d
878, 889 (Fed. Cir. 1988).

Determining whether an accused

product infringes the patent involves a two-step analysis.
Kegel, 127 F.3d at 1425.

The Court must first construe

the scope and meaning of the asserted patent claims and then
compare the accused product to the properly construed claims.
Id.
A.

The Asserted Claims and Claim Construction

Reckitt asserts claims 30, 35, 36 and 41 of the ’821 Patent
against Amneal, and claims 1 and 5 of the ’032 Patent against
Amneal and DRL. 10 The claims are as follows:
29. A modified release drug product comprising a first
quantity of guaifenesin in an immediate release
formulation wherein the guaifenesin becomes
bioavailable in a subject’s stomach; a second quantity
of guaifenesin in a sustained release form, . . .
30. The modified release drug product according to
claim 29, wherein a total quantity of guaifenesin is
from about 600 mg to about 1200 mg.
35. The modified release drug product according to
claim 30, wherein the guaifenesin has a Cmax of about

10

No testimony was presented at trial with respect to claims 2
and 6 of the '032 Patent as asserted in the SF, ¶ 25. Reckitt
does not dispute Defendants’ presumption that these claims have
been abandoned, and thus, this Court will consider them to have
been withdrawn by Plaintiff. Nor does it appear, despite the
assertions in the SF, ¶ 20, that any testimony was presented at
trial with respect to claim 70 of the ’821 Patent.
15

800 to 1250 ng/ml and an AUCinf of about 2800 to 4375
hr*ng/ml.
36. The modified release drug product according to
claim 30, wherein the guaifenesin has a Cmax of least
1000 ng/ml and an AUCinf of at least 3500 hr*ng/ml.
41. The modified release drug product according to
claim 29, wherein the drug product is approximately
equally effective when administered to the human
subject with an empty or full stomach.
’821 Patent (emphasis added).
1. A drug product comprising guaifenesin and having
two portions, wherein a first portion comprises
guaifenesin in an immediate release form, which
releases guaifenesin in a human’s stomach, and a
second portion comprises guaifenesin in a sustained
release form.
5. A drug product comprising guaifenesin and having
two portions, wherein a first portion comprises
guaifenesin in an immediate release form, which
releases guaifenesin in a human subject’s stomach, and
a second portion comprises guaifenesin in a sustained
release form, . . .
’032 Patent (emphasis added).
As noted, this Court adopted Judge Stark’s claim construction
from Aurobindo I as follows:
Disputed Word
“Portion”
“Modified release drug
product”

“Immediate release formulation
wherein the guaifenesin
becomes bioavailable in a
subject’s stomach”

Meaning
“a distinct formulation” (’032
Patent)
“a dosage form comprising a
sustained release quantity and
an immediate release quantity,
and having both immediate
release and sustained release
properties” (’821 Patent)
“a form intended to rapidly
release in the stomach
guaifenesin for absorption”
(’821 Patent)
16

“Release-delaying matrix”

“a combination of hydrophilic
and water insoluble polymers
of the sustained release
formulation which gels in the
stomach” (’821 patent)

Although the two formulations need not be physically
separate — except where there is a limitation regarding the
spatial orientation of them, like a bi-layered tablet — they
must be “inherently physically ‘separate’” because they are
distinct formulations. 11

This construction is in line with the

Federal Circuit’s decision that construed the same term in the
context of the related (not asserted here) ’252 Patent. See
Watson, 430 Fed. Appx. at 875-77.
The Aurobindo court, much like the Perrigo court, turned to
the Federal Circuit’s construction of the “portion” limitation
in the ’252 Patent.

See Aurobindo I, 2016 U.S. Dist. LEXIS

152337, at *6-8. The Federal Circuit construed “portion” as a
discrete part of the product.

Watson, 430 Fed. Appx. at 875-77.

Based on the nearly-identical language of the ’032 Patent, the
Aurobindo court construed “portion” to mean “distinct
formulation.” Aurobindo I, 2016 U.S. Dist. LEXIS 152337, at *6,

11

See Aurobindo I, 2016 U.S. Dist. LEXIS 152337, at *13. As
Judge Stark noted, the rejection of any particular spatial
relationship means that the two distinct formulations can be put
together in any tablet in any physical combination. Id.; see,
e.g., ’821 Patent, Col. 4:8-16. (describing beads or granules).
17

*8 n.5 (“[I]n order to avoid confusion .

.

. the Court has

(non-substantively) modified the Federal Circuit’s construction
of “portion” by substituting “distinct formulation” for
“discrete part of the product.”)

Similarly, regarding the ’821

Patent, as Judge Stark found and this Court adopted, the plain
language of the claim – a “modified release drug product”
comprising a “first quantity” 12 and “second quantity” of
guaifenesin – imposes a requirement that the product comprises
two distinct formulations. Id. at *12-13.
The parties squabble over whether “discrete” means
“distinct.”

Reckitt contends that the words have different

meanings and, thus, the Federal Circuit’s construction of
“portion” in Claim 1 as a “discrete part of the product” cannot
be squared under the doctrine of claim differentiation with
Claim 3 which provides “the drug product according to claim 1,
wherein the first and second portions are discrete.”

See

Watson, 430 Fed. Appx. at 876 (construing ’252 Patent).
Watson case involved a bi-layered tablet.

The

As the Watson court

explained, the two-portion limitation distinguished the product
from the defendant’s non-layered tablet. 13

12

The Aurobindo case,

The Court construed “quantity” to mean “amount.”
127].
13

[Docket No.

“The [Federal Circuit] also noted that the ‘discrete part’
construction ‘accurately encompass[ed] the three embodiments of
two-portion tablets and capsules disclosed in the specification’
18

like this case, however, did not involve a bilayer tablet.

The

Aurobindo court modified the construction by substituting
“distinct formulation” for “discrete part of the product.”
Aurobindo I, 2016 U.S. Dist. LEXIS 152337, at *8 n.5.

Notably,

the Aurobindo court declined to impose a construction that
required any particular spatial relationship.

Id. at *13.

The

Court ruled
To the extent the parties’ dispute centers on whether the
IR and SR formulations must be “physically separate,” as
in, for example, a bi-layered tablet . . . the Court finds
that the claims do not impose limitations regarding the
spatial orientation of the two. The Court recognizes that
the two different formulations of guaifenesin in the
claimed products are inherently physically “separate”
because they are distinct formulations. However, the
intrinsic record does not support additional structural or
spatial limitations being imposed by the word “portion.”
Id. (emphasis in original) (citation omitted).
As the court explained in its second opinion
In discussing spatial relationships, the Court
considered, and rejected, Aurobindo’s suggestion that
the claims require the two distinct formulations to
exist in a particular relationship, such as being
layered. But the Court’s rejection of any particular
spatial relationship simply means that the two
distinct formulations can be put together into a
of the '252 [P]atent, but did not suggest that the construction
was meant to limit the claims to those embodiments or others
like them.” Aurobindo I, 2016 U.S. Dist. LEXIS 152337, at *8
n.4 (quoting Watson, 430 Fed. Appx. at 877); see also '252
Patent Col. 3:57-60, 9:46-56 (describing three disclosed
embodiments: bilayer tablets having an IR portion on one face
and an SR portion on the other; bilayer tablets having an SR
portion in the center that is coated and surrounded by an IR
portion; and guaifenesin capsules containing beads of the IR
formulation and beads of the SR formulation).
19

tablet in any physical combination. See, e.g., '821
[P]atent col. 4 ll. 8-16 (describing tablet
embodiments composed of two types of beads or granules
mixed together; a sustained-release core with
immediate-release outer coating; or two layers). It
does not eliminate the requirement for two distinct
formulations, which are defined in the patents by
their ingredients. See, e.g., ’821 [P]atent col. 20
l. 54-col. 21 l. 37 (defining IR and SR formulations
by listing components).
Aurobindo II, 2017 U.S. Dist. LEXIS 31985, at *24 (emphasis
in original).
In this Court’s view, the Aurobindo court recognized that
Claims 1 and 3 used the terms “distinct” and “discrete” with
somewhat different meanings.

Although the words are often used

interchangeably, the Court finds that “discrete” in Claim 3
means “separate and distinct.”

See WEBSTER’S NEW WORLD COLLEGE

DICTIONARY 411 (Michael Agnes et al. eds., 4th ed. 2010).

Thus,

Claim 3 added a particular spatial relationship, see ’821 Patent
col. 4:10-12 (“beads or granules of both immediate release
formulation and beads or granules of sustained release
formulation”), not present in Claim 1. 14 Cf. Claim 4 (“The drug

14

Claim terms should generally be given their ordinary meaning
to a person of skill in the art at the time of invention.
Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir.
(2005)(en banc). To determine the ordinary meaning, the Court
looks first to the intrinsic evidence, which includes the
claims, the specification, and the prosecution history. Id. at
1312-17.
20

product according to claim 3, which is in a form of a bi-layer
tablet”).

15

15

Defendants moved, in limine, to exclude Dr. Davies’s testimony
on literal infringement because he applied the wrong claim
construction. [Docket No. 137]. Because this Court finds, for
the reasons infra that Dr. Davies’s testimony was not
persuasive, the motion is moot. The Court notes, however, that
Dr. Davies’s testimony as to the claim construction he used was
confusing. Dr. Davies testified that he did not believe
“distinct formulation” was the same as “a discrete part of the
product.” Tr. 286-290.
Q: Okay. When you read this definition that you put
in your report, the proposed construction, a discrete
part of the product or distinct formulation, did you
distinguish between a discrete part of the product and
distinct formulation in your mind?
A: I did. Well, I thought Amneal and DRL were because
it's either/or. It's either a discrete part of the
product or a distinct formulation, and I used the
distinct formulation as part of my opinions.
Q: Okay. So, you're saying that you understood the
proposed construction to be either/or; is that what
you're saying?
A: Well, I understood that they were saying it's a
discrete part of the product or a distinct
formulation, and I knew what discrete part of the
product meant in the context of the '252
[P]atent.
Q: Okay. I'm a little confused, sir. Are you saying
that you understood a discrete part of the product in
defendants' claim construction to mean something
different than distinct formulation in defendants'
claim construction?
A: I saw that as either/or, a discrete part of the
product or a distinct formulation, and I went on to
use the distinct formulation in my analysis.
21

B.

Infringement Analysis

The Court must next determine whether the accused product
contains every limitation of the properly construed claims.
Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1467 (Fed. Cir.
1998), abrogated on other grounds by Teva Pharm. USA, Inc. v.
Sandoz, Inc., 135 S. Ct. 831 (2015). 16

Thus, the relevant

question is whether the Defendants’ ANDA Products contain two
distinct formulations, an IR Formulation and a SR Formulation.
Because Reckitt believed that the Aurobindo court had granted
summary judgment against it due to Reckitt’s failure to present

Q: And when you say it's either/or, you thought that
those were alternative definitions?
A: Again, I did not think distinct formulation was
the same as discrete part of the product in that
context.
Tr. 288-89. He did admit, however, that if the Court finds that
there is no substantive difference between distinct and
discrete, there would be no infringement. Tr. 412-13 (“If the
Court finds . . . that the discrete and distinct portions are
the same as were the '252 [P]atent, then I would agree.”)
16

The parties appear to agree on the definition of a person of
ordinary skill in the art (“POSA”). See Plaintiff’s Contested
Facts [Docket No. 157], at ¶ 6-7, which does not appear to be
contested by Defendants. “A person of ordinary skill in the art
for the ’821 and '032 Patents would be, for example, a scientist
with a graduate degree in pharmacology, pharmacy, or
pharmaceutical chemistry, or a scientist with lesser formal
training complemented with suitable professional experience.”
Id. at ¶ 7.
22

any evidence of structural or spatial limitations, 17 the trial
before this Court primarily involved testimonial evidence
focused on that issue.
1.

Dr. Davies’s Raman Imaging

Reckitt introduced the testimony of Dr. Davies who relied
on Raman chemical imaging maps of Defendants’ Products to
attempt to show that the accused products have a distinct IR
formulation on the surface and a distinct SR formulation below
the surface.

Tr. 98:24 – 99:7.

In general, Dr. Davies

identified a region where there was guaifenesin and other
excipients, without

(a rate-changing polymer), on and

near the surface of the tablets from which guaifenesin would
rapidly release, i.e., an IR portion. He then identified another
region beneath the surface of the tablets where the rate of
guaifenesin would be slower, i.e., an SR portion, because
is present, which effects the release of guaifenesin.
Dr. Davies then testified how the IR and SR portions were, in
his opinion, distinct in location, composition, and in release
properties.
Defendants argue that the analyses done by Dr. Davies are
flawed for numerous reasons.

Principally, Defendants aver that

17

As Judge Stark noted, “the intrinsic record does not support
additional structural or spatial limitations being imposed by
the word portion.” 2016 U.S. Dist. LEXIS 156337, at *13.
23

Dr. Davies’s images merely portray what is well known, that in a
non-coated tablet there is always guaifenesin on the surface
that rapidly dissolves in the stomach before the ratecontrolling polymers have swelled to exert a rate-controlling
effect.

Defendants also contend that Dr. Davies equated two

distinct formulations with dissolution behavior, a theory
rejected by the Aurobindo court.

See Aurobindo II, 2017 U.S.

Dist. LEXIS 31985, at *18, 19-23 ("[That the drugs have similar
dissolution profiles] is unsurprising, as bioequivalence to an
already-approved product is a requirement for ANDA approval”).
The Court now turns to the parties’ analyses of the evidence.
As an initial matter, the parties do not dispute that Raman
microscopy testing is used in the pharmaceutical industry as a
means to characterize the structure of solid oral dosage forms.
Tr. 134:17-20.

Raman spectroscopy and microscopy produces

unique chemical fingerprints which may enable a person skilled
in the art to identify the molecules at any given position.

Id.

at 134:21-23.
As part of his Raman analysis, Dr. Davies cut a single
tablet of each of the Defendants’ products in half and then used
a microtome to obtain an extremely thin and flat substrate for
imaging.

Id. at 135:6-12.

imaging was two microns.

The spot size of the laser used for
Id. at 139:9.

After a spectrum was

obtained the laser moved to a new spot five microns away to
24

repeat the process.

Id. at 139:14-16.

acquisition time was 400 milliseconds.

For each spectrum, the
Id. at 139:21-22.

This

process was repeated 230,000 times and each spectrum was matched
to a compound, using K-means cluster analysis, and a
corresponding location in order to create a colored Raman map.
Id. at 145:21; 176:17-177:10.
a.

Imaging of DRL Tablet

Dr. Davies generated the following two maps which he
testified are representative of the structure of DRL’s tablets
(PTX 35).

In the third
demonstrative map (PDX 237), the red arrows illustrate where,
allegedly, guaifenesin is present on the surface.

(PTX 35)

25

(PDX 237)
According to Dr. Davies, the surface of DRL’s tablet was
“dominated” by guaifenesin.

Tr. 147:25-148:15.

He explained

that regions on and near the surface of DRL’s tablet dominated
by guaifenesin and other excipients, but without the ratecontrolling

polymers, constitute the first portion of

guaifenesin in IR form.

Id. at 148:15-20.

Because the

guaifenesin present in the IR region is uninhibited by
(which is rate-controlling), it rapidly releases in the gastric
fluid upon contact.

Id. at 148:21-23.

rate in the first hour is about 23%.

The consistent release
Id. at 118:20-24.

In his

opinion, this is a distinct immediate release formulation within
the meaning of the asserted claims.

Id. at 118:22-25; 191-198.

Dr. Davies further testified that DRL’s products contain a
second portion of guaifenesin in SR form, which is guaifenesin
in the interior of the tablet in the presence of the rate-

26

controlling polymers, a second formulation within the asserted
claims.

Id. at 118:25-119:4; 191-198.
b.

Imaging of Amneal Tablet

Dr. Davies also generated the following map (PTX 36), which
he testified is representative of the structure of Amneal’s
tablets:

(PTX 36)

(PDX 241)
Similar to the DRL tablet, the red arrows in the
demonstrative map above, (PDX 241), illustrate where guaifenesin
is present on the surface of the Amneal tablet.

According to

Dr. Davies, the surface is dominated by guaifenesin and other
excipients without Methocel, which constitutes the IR
formulation.

Id. at 160:6-10.

Dr. Davies testified that

Amneal’s tablets provide a consistent release in the first hour,

27

about 20% and 24% for the 1200 mg and 600 mg products,
respectively.

Id. 422:6-10.

immediate release formulation.

In his opinion, this is a distinct
Id. at 160:7-9.

He further

provided that, similar to the DRL tablet, the guaifenesin below
the surface is inhibited by the rate-controlling polymers and is
the SR distinct formulation.
2.

Dr. Davies’s Analysis is Flawed and
Unreliable

Because the parties spent a considerable amount of time
either defending or attacking Dr. Davies’s Raman analyses, the
Court first turns to some of the parties’ specific arguments. In
the Court’s final analysis, however, it is not so much that Dr.
Davies’s images were flawed — as they were for the reasons set
forth herein — but that his interpretation of those images was
fundamentally flawed.

Defendants argue as a general principle

that Dr. Davies’s Raman maps should be given no evidentiary
weight because they are nothing more than “window dressing.”
They essentially rely on an exchange between Dr. Davies and the
Court:
The Court: But it seems to me, correct me if I’m
wrong, that if you have to do content blending,
uniformity blending, you are going to get this
mixture. You know the significant percentages of
guaifenesin going into it. It seems to me that that
picture could have been painted without the imaging.
The Witness: Your Honor, to me it could because . . .
I think looking at the dissolution and the PK data,
somebody of ordinary skill in the art would know that
28

such formulations would be able to achieve that
because they have the first portion and an immediaterelease portion and they have a sustained-release
portion that can give you that long term effect. It’s
– I guess we’re here because Judge Stark said that
they had – you had to show it physically.
Tr. 365:7-366:1 (emphasis added).
Dr. Davies’s answer to the Court’s question does hint that
he conducted a structural analysis to “mask [his improper]
reliance on the dissolution rate of guaifenesin” as Defendants
argue, Def. Resp. Post-Trial Br. at 1 [Docket No. 180], a theory
the Aurobindo court had rejected.
28.

Def. Resp. Post-Trial Br. at

Indeed, as set forth below, it was this Court’s overall

impression that Dr. Davies believed that the dissolution
behavior alone was evidence enough that the Defendants’ products
have two infringing distinct formulations.

Given that firmly

held opinion, Dr. Davies labored to convince not only this
Court, but himself, it seemed, that his analyses showed two
distinct formulations.

This may help explain why Dr. Davies’s

opinions at times came off as either creative or conclusory, as
the Court explains below.

Setting these general criticisms

aside for the moment, the Court now turns to the specific
arguments the Defendants have made against his structural
analyses, before addressing his flawed interpretation of such
analyses.

29

Dr. Davies explained that the black, unidentified pixels on
his map of Amneal’s tablet (see PTX 35 supra) were the result of
fluorescence between the dye and the Raman laser.
434:1.

Dr. Rogers, however,

Tr. 433:23-

explained that what Dr. Davies

described as fluorescence interfering with the Raman signal
essentially means that the data is “botched” and he should have
performed the Raman testing more times to obtain better data.
Tr. 907:9; see also Tr. 911:2-5 (“Fluorescence from the blue dye
could cause the entire background to be so high that nothing
would be identifiable, so the large black voids appear
throughout the interior of this map.”)

Additionally, he

testified that the Raman map was littered with far more black
areas than just the large black voids in the center; he enlarged
the map to illustrate this problem.

Id. at 915-917, 916:1-11

(“I just want to draw your attention to all of the black, all of
these black areas, which in Dr. Davies’s map are indicated as
unidentified areas . . . .

But if you go past the black voids

and if you pay attention to both what’s called the surface and
what’s called the interior, this entire map is filled with
unidentified regions”).
In the Court’s view, Dr. Rogers persuasively testified the
image was neither complete nor an accurate representation of the
structure of the ingredients within Amneal’s tablet.
911:23 – 912:4.

Id. at

Dr. Davies’s assertion that the majority of the
30

unidentified pixels were in the interior of the tablet, the
supposed SR portion, and therefore the fluorescence did not
interfere with his ability to distinguish an IR portion was not
convincing.

Additionally, Dr. Davies’s testimony that he was

unable to eliminate the fluorescence with the dye makes the
Defendants’ point.
Dr. Rogers also criticized Dr. Davies’s images because half
of the ingredients in the tablet were not detected. 18
921:13-23.

Tr.

Although Dr. Davies agreed that the map he created

for Amneal was “incomplete,” Tr. 428:11-15, he disagreed that
his analysis was affected by the non-appearance of this group of
compounds because they are not involved in the release of
guaifenesin.

Tr. 166:16-24.

Dr. Rogers agreed that four of the

ingredients, talc, colloidal silicon dioxide, magnesium
stearate, and povidone, were not added to control the rate of
release of guaifenesin, 19 Tr. 965:24–966:3, but disagreed that
carbomer did not exert a rate-controlling effect.

18

Five ingredients, carbomer 934P, povidone, colloidal silicon
dioxide, talc, and magnesium stearate, making up about 8% by
weight of the ingredients were not detected in Dr. Davies’s
Raman map.
19

First, Dr. Rogers agreed that talc is used as a glidant and
that its weight percentage in the formulation is 0.44%. Tr.
964:8-17. Second, Dr. Rogers agreed that colloidal silicon
dioxide is also used as a glidant and that its weight percentage
in the formulation is 0.44%. Id. at 964:20–965:5. Third, Dr.
Rogers agreed that magnesium stearate is used as a lubricant and
that its weight percentage in the formulation is 0.95%. Id. at
31

More specifically, according to Dr. Davies, carbomer only
begins to swell and exert a rate-limiting effect once the pill
reaches the basic conditions of the small intestine.
155.

Id. at

In support of this testimony, Dr. Davies cited an excerpt

from the Handbook of Pharmaceutical Excipients (PTX 106) that
showed carbomer was a weak acid.

Id. at 167-168. 20

Therefore,

Dr. Davies testified, because the tablet takes about two hours
to reach the small intestine, and because the IR portion is
released within the first hour, carbomer does not affect the IR
portion of the tablet.

Id. at 156:6-7.

In contrast, Dr. Gemeinhart, a pharmaceutical scientist who
conducts research on polymers and studies carbomer and other
polyacrylic acids, testified that carbomer will gel during the
timeframe of any potential IR formulation.

Tr. 748:3-16.

Dr.

Gemeinhart testified that in the low pH of the stomach, the

965:8-13. Finally, Dr. Rogers agreed that povidone is used as a
binder and that its weight percentage in the formulation is
5.70%. Tr. 965:17-23.
20

According to the Handbook “when neutralized, carbomers produce
highly viscous gels.” Tr. 961:8-11; PTX 106, at 5. Dr. Rogers
agreed that the more viscous the gel, the more likely it is it
will act as an inhibitor. Tr. 961:8-19. Additionally, the book
stated that the “viscosity [of carbomers] is considerably
reduced at pH values less than three” and Dr. Rogers agreed that
pH levels in the stomach are normally less than three. Id. at
962:1-6. In further support of Reckitt’s position, Dr. Davies
cited an excerpt from Amneal’s ANDA indicating that the compound
won’t start to ionize until about pH 4.5, at which time it will
swell much more readily. Tr. 169-170.
32

polymer forms a less swollen network than in the higher pH of
the small intestine; however, in the stomach there is still a
swollen network.

Id. at 710:4-10.

This means that carbomer

will exert a rate-controlling effect on drug release while the
tablet is in the stomach.

In support of his position, Dr.

Gemeinhart cited a research article titled “A Novel Method to
Study the Effect of pH and Excipients on Water Uptake and
Swelling Behavior of Carbopol Polymers” (DTX 82 (the “Sharmin
article”)).

21

Id. at 711:1-104; 712:4-7 (“[I]t clearly says the

extent of swelling is less when it is in that lower pH in the
stomach. But, it clearly doesn’t say that it doesn’t exist, it
just says less.”) (emphasis added).

Dr. Gemeinhart highlighted

a graph (DTX 82-5) that demonstrates a difference between the
swelling of carbopol in distilled water and in acid comparable
to gastric fluid, but still shows that for a 200 mg tablet in
acid, there is an increase of two times the amount of mass of
water within one hour. 22

Id. at 712:11-713:15.

According to Dr.

Gemeinhart this clearly shows carbopol will be taking up a

21

It is not in dispute that carbomer and carbopol are used
interchangeably at times.
22

On cross examination, Dr. Gemeinhart admitted that this
experiment was performed with tablets that were 100% polymer and
lacked any active ingredient. Tr. 835:9-11.
33

significant amount of water in acid solutions.

Id. at 713:17-

18.
Reckitt takes issue with Amneal’s reliance on the Sharmin
article, contending that it dealt with experimental tablets that
were 100% carbomer, unlike Amneal’s tablets which are less than
1% carbomer.

Dr. Davies accuses Dr. Gemeinhart of comparing

“apples and oranges.”

Tr. 171:7.

Nonetheless, the parties

appear to be in agreement that carbomer does not have the same
level of rate-controlling effect in the low pH environment of
the stomach as it does in the higher pH environment of the small
intestine.

The Court, however, is persuaded by Defendant’s

evidence that carbomer nonetheless exerts some rate-controlling
effect in the stomach.

At best, Dr. Davies’s testimony served

to support the finding that carbomer has less of a ratecontrolling effect in the stomach, but it did not contradict Dr.
Gemeinhart’s testimony that carbomer has some rate-controlling
effect.

Hence, that carbomer does play some role in the

dissolution of Amneal’s tablets should have been accounted for
by Dr. Davies in his Raman analysis.
weakens his analysis.

The failure to do so

In short, the Court agrees with

Defendants that Dr. Davies’s disregard of carbomer in his Raman
testing makes his Raman images less reliable. 23

23

Because the Court need not rely on Dr. Rogers’ testimony
regarding Dr. Davies’s reliance on reference spectra from a
34

DRL argues that, like Amneal’s map, Dr. Davies’s maps of
its tablet did not include
Tr. 312-315.
This criticism carries little weight as it is undisputed that
these

ingredients do not affect the rate of release of

guaifenesin, and
More importantly, however, DRL argues that because Dr.
Davies was not able to accurately image all of the
the tablet, his Raman maps were fundamentally flawed.

in
DRL

presented the testimony of Dr. Spingarn who testified that with
Raman spectroscopy it is easy to identify a strong emitting
compound that is in a high concentration, but difficult to
identify a weak emitting compound in a low concentration.
984:12-21.

Because

Tr.

is present in a relatively low

concentration

and because

is less

than a tenth as strong of a Raman emitter as guaifenesin, he
testified that it is likely it would be difficult to identify
but easy to identify the distributions of guaifenesin.
Id. at 985-86 (referencing DDX-301).
To prove the point, Dr. Spingarn produced a univariate
(single frequency) map of the

textbook, Reckitt’s objection to such testimony is dismissed as
moot. See Tr. 919-921.
35

using Dr. Davies’s data.

Dr. Spingarn explained that a

univariate map extracts spectra at a single frequency.
994:20-21.

Because

Id. at

have similar spectra,

the map contains the distribution of both compounds and does not
differentiate between them.

Id. at 998-999.

Unlike Dr.

Davies’s Raman maps, Dr. Spingarn’s univariate maps, two of
which are shown below, included the intensity data for each
corresponding spectrum, with higher intensity corresponding to
brighter colors.

Tr. 991:20-21.

Dr. Spingarn explained that a significant number of green
pixels could be seen outside the known area of the tablet
because of noise in the data.

Id. at 1000:1-11.

Dr. Spingarn

testified that there is a level of green pixel intensity
throughout the tablet that is very similar to the noise level;
therefore, it will be difficult to identify
within that area.

Id. at 1001-1002.
36

Dr. Spingarn testified:

And the obvious question you might ask is, why are
there all those green pixels outside the area of the
map. The important thing to remember is, I'm not
processing anything, I'm not generating this. This is
the data that exists within Dr. Davies’s maps. That is
to say, this area outside the tablet is undoubtedly
noise. We have no reason to suspect that there is an
abundance of
outside the tablet
off the area
but what we have out
there is noise, and we will have to understand noise
to understand why we have a lot of problems or why Dr.
Davies has a lot of problems with his imaging of

Now, we do see some
crystals of either
from this map which
compare them to Dr.
spots correspond to
painted on his map,

nice bright spots and those are
We don't know
ut if we
Davies’s map, all of those bright
the dark blue areas that he
which he identifies as

So if we know that all the bright spots are
then the question is, where are the bright s
and that's the question that we ultimately
nswer, where is the
Tr. 1000:1-21.
Reckitt disputes DRL’s contention that Dr. Davies’s map
reflected only the largest, most intense particles of
Specifically, Dr. Davies testified that he could
resolve

particles unless they were smaller than 2

microns (Tr. 182:11-15) and according to the manufacturer of

Moreover, focusing on a single peak as a univariate
analysis does is a less valuable tool.

Dr. Spingarn appeared to

have agreed with some of Dr. Davies’s criticisms.

Tr. 996:9-10

(“When you’re doing a data analysis, you always want to start
37

with the simple way of looking at [the data].”); Tr. 1070:11-17
(“Q: But you agree with me if there is more information
available to you about a particular material you are examining
it might help to look at all that information and consider that
in making an identification of the material that’s being
examined right?

A: Correct.

And that’s why people do

multicomponent resolution, they are K-mean cluster.”)
Dr. Spingarn responded to Dr. Davies’s criticism of his
univariate analysis by analyzing Dr. Davies’s K-means cluster
analysis, which is a multivariate (“looking at more than one
thing at a time”) analysis.

Tr. 995:11-12.

As Dr. Spingarn

explained, K-means cluster analysis divides the data into
“clusters” based on similarities between spectra.

Dr. Spingarn

concluded:
A: Sure. When we look at the cluster averages that Dr.
Davies presented in his data production, those data
cluster averages, the cluster average for
has
a bigger peak for guaifenesin in it than i
or
What that means is, if you take all of the
els, his map, all of them together, average
them, the green pixels, which he characterizes as
being
peaks, have a larger guaifenesin peak
in it
peak.
That means that all of those things that he has green
dots on are combinations of guaifenesin and
they are not pure
peaks the way Dr.
s
characterizing the
s map would mislead you to
believe, and that is a critical point in understanding
the problems with this map.
Tr. 1026:9-21.

38

The Court finds Dr. Spingarn’s testimony persuasive.
Although Dr. Davies attempted to explain the guaifenesin peaks
in his spectra by stating that they are the result of “edge
effects,”

Tr. 350:7-15; 358:12-20, 359:13-18,

Dr. Spingarn

credibly explained this could not be true. 24

Edge effects occur

when the Raman laser hits between a

particle and a

guaifenesin particle, and some guaifenesin signal is introduced
into the

spectrum.

Id. at 1026. Dr. Spingarn used a

cross section of one of Dr. Davies’s own Raman images, (DDX
321), specifically focusing on one

pixel, to illustrate

that Dr. Davies’s “edge effects” theory cannot explain every
situation in which guaifenesin peaks appear in a
labeled spectrum. 25 Dr. Spingarn explained that guaifenesin peaks
in a

pixel at least “five . . . [to] seven pixels away

[from any guaifenesin pixel],” could not be the result of edge

24

Reckitt objects to any of Dr. Spingarn’s testimony regarding
“edge effects” because he, Dr. Spingarn, never offered such
opinion in his expert report. Defendants maintain that Dr.
Spingarn’s opinion was elicited as a response to Dr. Davies’s
testimony elicited on cross-examination. Because this Court
finds that this topic was well within the scope of Dr. Davies’s
expert report, but he did not discuss it, and Defendants first
learned of it on cross-examination, such testimony is proper.
Newman v. GHS Osteopathic, Inc., Parkview Hosp. Div., 60 F.3d
153, 156 (3d Cir. 1995) (discussing courts’ “discretion” in
determining whether to exclude evidence for violation of Fed. R.
Civ. P. 26).
25

The corresponding spectrum of the pixel identified in (DDX
321) contains guaifenesin peaks.
39

effects; therefore, in at least one documented case Dr. Davies’s
Raman laser picked up more than one compound.

Tr. 1034:10-17.

The Court credits Dr. Spingarn’s testimony that the Raman laser
often landed on more than one particle, which resulted in the
average cluster spectrum for
guaifenesin peaks.

containing strong

As guaifenesin is by far the strongest Raman

scatterer in the tablet, the Court is not persuaded that the
guaifenesin peaks in the

spectra indicate that Dr.

Davies has overrepresented the amount of

in the tablet;

instead, Defendants’ experts have persuaded the Court that it is
far more likely that guaifenesin obscured

in the

tablet.
Dr. Davies’s testimony that the surface of each of the
Defendants’ tablets was dominated by guaifenesin fares no
better.

Dr. Spingarn persuasively testified that if one wants

to draw quantitative conclusions from Raman mapping, this
requires statistical representations and one tablet would not be
anywhere near adequate for reaching quantitative conclusions.
Id. at 1042:23–1043:5.

He further clarified that quantitative

conclusions include conclusions about the concentration of
ingredients in particular areas of the tablet.

Id. at 1043:6-9.

Similarly, Dr. Rodriguez, a computer imaging expert, was
asked by DRL to analyze two of Dr. Davies’s images by
calculating the percentage of pixels colored red and green
40

respectively in each of the two images, and also to perform that
calculation pixel layer by pixel layer.

Tr. 1081-82.

In order

to achieve this, Dr. Rodriguez first wrote a computer program
and then took the electronic file representing Dr. Davies’s
opening report and extracted the images in order to obtain the
pixel data without the superimposed white and black circles. 26
Id.

Finally, Dr. Rodriguez utilized the computer program to

count the red and green pixels layer by layer and additionally
calculated the percentage of each colored pixel in each layer.
Id. at 1084-85.
Dr. Rodriguez testified that the average percentage of the
red pixels for the first four layers is 95.87% and also that the
average percentage of green pixels for the first four layers is
1.625%.

Id. at 1099:25–1100:7.

More importantly, Dr. Rodriguez

testified that his pixel count could not be used to draw
conclusions about the amount of guaifenesin on the surface
because he did not have either volumetric information about the
pixels or quantitative information about how much of each
ingredient was present at a given pixel location.

Id. at 1090.

Although Dr. Davies testified that this information supported
his conclusion that there was a distinct IR formulation and that
it confirmed an enrichment of guaifenesin on the surface of

26

DDX 402.
41

DRL’s tablet, Tr. 145-149, the Court does not agree.

Dr. Davies

conceded on cross examination that Dr. Rodriguez’s pixel count
could not be equated to concentration and instead his opinion
rested on the simple relative proportion of guaifenesin as
depicted by the pixels.

Tr. 308:15–309:12 (“I’m not converting

the 96 percent guaifenesin into weight as in composition.”).
In the end, the Court finds that Defendants’ criticisms of
Dr. Davies’s Raman analyses were well-placed and called into
question the reliability of Dr. Davies’s opinion.

However, as

alluded to above, Dr. Davies’s interpretations the maps created
by those analyses present a greater issue.

Dr. Davies’s

testimony leads this Court to the conclusion that, with some
creative thinking, one could define any region of a tablet as
having a distinct formulation.

Dr. Spingarn expressed this very

concept:
“[Y]ou could circle any region of this [map] with a
small enough circle or a large enough circle to come
up with another mix of ingredients. You could come up
with an infinite number of formulations if a
formulation is defined as a group of components inside
one microscopic volume of a tablet . . . . What this
is, is quite clearly a random assortment of or uniform
distribution of components throughout the tablet.
There is no evidence of any distinct formulations
other than that which comprises the entire tablet.
Tr. 1040:5-15.
Most troubling was Dr. Davies’s concession that an SR
formulation could be transformed into an IR formulation simply

42

by cutting off the original surface of the tablets.

No matter

how many times the tablet was cut, the outer layer would
transform into the IR formulation even though it had been the SR
formulation.

During questioning by counsel for DRL, Dr. Davies

testified
Q: . . . [Y]ou’ve postulated that the immediate
release is at the surface, okay? So I’m saying, if I
cut that surface off and now I’m in the part that
you’ve defined or at least you originally defined the
sustained-release formulation, by your logic, that new
surface has become an immediate release formulation,
right?
. . .
The Witness: Yes.
The Court: That you have now converted what you said
was a sustained-release formulation, now becomes an
initial release formulation because it’s exposed. Do
you agree with that?
The Witness:
Tr. 395:19-396:8.

I do.
During the same cross-examination by DRL’s

counsel, Dr. Davies further stated that
Q: . . . if I took a knife . . . and I cut this tablet
in half, right through the center of your black
circles . . . This surface here, this newly-exposed
surface that you have characterized as a sustainedrelease formulation, right?
A: Yes.
. . .
Q: Regardless, sir, in this new surface, this – the
formerly sustained-release surface, now I have a lot
of exposed guaifenesin, right, and there’s no

43

at least on parts of it, so that’s going to
ccording to you, right?
A: I agree that you’ve changed the formulation . . .
You changed the composition, you’ve changed the
location, so, therefore, this would be a different
formulation.
. . .
Q: . . . So I’m saying, if I cut that surface off and
now I’m in the part that you’ve defined or at least
you originally defined as the sustained-release
formulation, by your logic, that new surface has
become an immediate-release formulation, right?
. . .
THE COURT: Do you agree with that last sentence?
THE WITNESS: Yes.
Tr. 393:16–396:3.
This testimony alone, it seems, should end the inquiry as
to whether Defendants’ tablets have two distinct formulations
necessary for a finding of infringement.

If changing the

location of an SR formulation can transform it into an IR
formulation without changing the composition of that
formulation, both formulations necessarily are not distinct.
See Id. at 933:19-25 (“If I cut it that way or I cut it this
way, this that was clearly identified as sustained release would
automatically become immediate release, simply because the
tablet was cut in half.
formulations.

That’s not indicative of two distinct

That’s indicative that there’s one formulation

and it goes throughout the tablet.”) (testimony of Dr. Rogers);
44

see also Id. at 618:9-16 (“[W]e know what exists from the
manufacturing process.

We know there is a uniform distribution

of ingredients in the tablet.

And so therefore, if I cut off

any portion of the tablet, let’s say in the dry state, and then
swallow that, that cut off portion will undergo the exact same
wetting process and dissolution as before.

Just cutting off the

surface of a homogeneous tablet cannot change the mechanism,
because everything is the same throughout.”) (testimony of Dr.
Brittain).
Moreover, in describing the location and shape of the IR
formulation, Dr. Davies acknowledged that the location of what
he viewed to be the IR portion (which may at one time have been
the SR portion, supra) would vary not only from tablet to
tablet, but within a single tablet.

Dr. Davies agreed with this

Court’s question that the IR formulation would resemble an
“upside down mountain range.”

Tr. 259:14–260:20 (“[I]n some

areas you’re going . . . to go way further down in because
there’s only guaifenesin.

In some areas . . . it’s right at the

surface . . . so . . . you’re going to have jagged teeth
throughout”).

As counsel for DRL aptly noted at closing

argument:
[t]he problem is I don’t know what that means, neither
does a POSA. Are we talking about the Himalayan
mountains, are we talking about the Watchung Hills?
There’s no shape to it, there’s no dimension, there’s
nothing that a POSA could say, oh, there’s the
45

immediate release portion . . . . There’s no way to
define it except if you could go back after the tablet
is dissolved and somehow reconstruct what the outline
was of this stuff that dissolved in the first hour.
Closing Arguments Tr. 83:1-9 [Docket No. 197].
agrees.

The Court

A “you’ll know it when you see it” approach hardly

meets the structural claim limitation.
Moreover, when the Court inquired further as to whether the
“upside down mountain range” would vary from tablet to tablet,
Dr. Davies indicated it would.

Tr. 260:21-25.

He went on to

explain:
It could look different, in terms of its shape, but
the overall effect from tablet to tablet would be the
same because we -- from the dissolution data, the
burst effect, we know that occurs with both DRL and
Amneal’s tablet.
Id. at 260:25-261:4 (emphasis added).

Dr. Davies’s answer,

not surprisingly, reveals that Dr. Davies returned to his
misplaced reliance on the dissolution data.
Furthermore, Dr. Davies was unable to adequately describe a
consistent method for determining which parts of the tablet
would swell and control the rate of release of guaifenesin.

As

discussed supra, Dr. Davies testified that the IR formulation is
the guaifenesin that is present at the surface in the absence of
and the SR portion is the drug in the presence of
excipients with the rate controlling polymer.
also testified that “[i]f you have

46

Yet, Dr. Davies

right on the

outside, because the drug here has been dissolved, it’s likely
that the

will be swept away in that initial rapid

dissolution, whereas the
start to hydrate.”
442:16-442:20.

that’s in the bulk here will

Tr. 263:6-14; see also id. at 451:16-452:2;

In other words, Dr. Davies seems to have

acknowledged that the compositions of his two formulations could
have the same ingredients.

This, however, contradicted his own

ingredients-based approach (guaifenesin versus guaifenesin and
to differentiating the IR and SR formulations. 27
The above testimony also demonstrated that Dr. Davies’s
definition of “surface” was less than clear.

On DDX 100, Dr.

Davies drew white circles (below) to illustrate regions of
guaifenesin on the surface of the tablet formulation.

(DDX 100)

27

The Court notes that Dr. Davies did not provide a measure of
when enough
is present to prevent it from falling away
at the surfa
47

According to Dr. Davies, the guaifenesin on the surface –
again, as illustrated by the white circles - will rapidly
dissolve, thus constituting the IR formulation.

The SR

formulation begins acting once the guaifenesin comes into
contact with the rate-controlling polymer, which will start to
hydrate and form the gel layer.

Tr. 258.

The problem with Dr.

Davies’s testimony, however, is that the surface as he defined
it, the “area at the surface and just below the surface where
there is drug present in an immediate release form,” Tr. 257:1619, included not only

particles on the surface but

particles under guaifenesin on the surface.

Tr. 261-

262.
Dr. Davies was more definitive that the guaifenesin on the
surface would rapidly dissolve than he was about the guaifenesin
that was near the surface with

around it.

THE COURT: Why is the guaifenesin below the
? Why do you say it's an immediate release?
THE WITNESS: Because, Your Honor, if you look below -if we're looking at this particular part, you see
you've got some
here. If you have
right
tside, because the drug here
issolved, it's likely that the
will be swept away in that initial rapid
n,
whereas the
that's in the bulk here will
start to hyd
THE COURT: It sounds like you're not -- you don't
really know. You would have to sort of do an analysis
to see.

48

THE WITNESS: Well, it's not so much -- I know how
these formulations work, I've studied them for many
years, Your Honor. But –THE COURT: But how would a POSA know, looking at -how would a POSA know what it is that it's doing?
Whether it's an IR or an SR, how would they know?
THE WITNESS: Oh, a POSA would know looking at this
that there is guaifenesin on the surface. The POSA
would know straightaway that that's an immediate
release form, because it's in the absence of the ratecontrolling polymer.
THE COURT: Yeah, but how would a POSA know -– going
back to the question that Ms. HUTTNER is asking you,
the guaifenesin right below the
, whether
it's an IR or an SR.
THE WITNESS: A POSA would know that just the position
as described is very close to the surface, which is
known, will produce the burst effect.
THE COURT: Even with the rate-controlling polymer
ahead of it?
THE WITNESS: Yes, the rate-controlling polymer is
likely to fall away at the surface because of the very
fact that it's having this burst effect. You're having
this rapid dissolution of the drug, it's falling off
the surface. But as that solvent ingresses, you then
meet more of the rate-controlling polymer, which
starts to form the gel structure.
Tr. 263:6-264:23.
The Court pressed Dr. Davies as to whether a non-infringing
tablet could be made without a coating containing a ratecontrolling polymer
THE COURT: Okay. So, I'm going to box you in here.
Tell me the two distinct formulations in your opinion.
THE WITNESS: Two distinct formulations in both of
these formulations is the guaifenesin present with
49

excipients on the outer surface of these tablets in
the absence of the rate controlling polymer which
provides that burst release, so it's like the core
coated -- the immediate-release layer on the core
coated tablet. The sustained-release portion is where
-- and that provides the burst, provides the Cmax. The
sustained-release portion is that portion where the
guaifenesin is present below the surface in the
presence of the rate controlling polymers which
control the release of the drug.
THE COURT: And so –THE WITNESS: And provide that 12 hours.
THE COURT: -- is it your testimony then that the only
way that a non-infringing sustained-release tablet
could be made is by having a coating of a rate
controlling polymer?
THE WITNESS: No, I think -- I thought about that. I
think if one was -- one way to do it is to actually
increase the level of polymer to drug, and in those
cases you will reduce or eliminate the burst effect.
But that –Tr. 340:8-341:4.
Yet, Dr. Davies could offer little clarity on how he
defined a burst effect
Q: Okay. And are you equating -- are you saying that,
and I was going to ask you more specifically what do
you mean by burst or how big does the burst have to be
to matter, but as a foundation question, are you
saying that you are equating the immediate release
formulation with what we call the burst effect, or
what you call the burst effect?
A: I am equating the first portion which is related to
the burst effect, because the burst effect is caused
by the presence of drug in the immediate release form.
Q: So let's put a finer point on it. How big does the
release of guaifenesin have to be and over what time

50

period does it have to happen for you to consider it
to be a burst?
A: It depends. It depends what you mean by that, if
you mean –Q: Well, it's your term, sir, your term "burst." What
I'm asking you is to define what you mean, because
you've equated burst and immediate release
formulation, I'm asking you to define for us what you
mean by a burst, how much guaifenesin has to be
released and how quickly does it have to be released
to qualify as a burst, in your opinion?
A: Thank you. I believe the immediate release
formulation that's present in the formulations that we
see here today provide a burst effect in the first
hour of the -- and that's clear from the -- both the
dissolution data and it's also clear by the PK data,
clearly within that first hour of the amount that is
released from the first portion will also be -- there
will be additional drug released from sustained
release portion just as there is in the Mucinex®.
Q: Okay. I'm not sure I heard any words that you said,
but I did hear you say, that in terms of time frame,
you're putting an hour, you are defining it -- burst
as something has to happen within an hour, right?
A: The burst will happen within the first hour, that's
correct.
Q: All right. And in terms of the size of the burst,
you, made reference to DRL’s ANDA formulation, that
releases about -- I think it's somewhere between 22
and 25 percent of guaifenesin in the first hour,
right?
A: That's correct.
Q: And I guess the question is, if it's 20 percent, is
it still a burst?
A: It would be a burst, yeah.
Q: How about 15?

51

A: It depends on the -- again, looking at the
dissolution profile, it would depend on the profile
but it could be a burst, yes.
Q: How about 10 percent?
A: Again, it depends how much of the formulation, if
there is just 10 percent released in the first hour,
that may indeed be a burst effect, but it could be off
a polymer system where there is much more polymer so
there is much -- little less burst released.
Q: Well, sir, I guess it begs the question, if you are
a manufacturer like DRL and you are trying to respect
the patent rights of -- in this case of Reckitt
Benckiser and you want to make sure you don't have a
burst effect, if we hypothetically accept your opinion
that that equates to an immediate release formulation,
how do you know?
A: How do you know what?
Q: How do you know if you have a burst effect based on
what I've asked you?
A: Oh, of course, DRL and Amneal know they have burst
effects, their scientists say they have a burst
effect.
THE COURT: The question is, how do you know how to
create a tablet that doesn't have the burst effect?
THE WITNESS: Amneal knew what they were doing in
making that formulation, how would you make an
alternative formulation?
THE COURT: Excuse me, that wasn't the question. The
question is, how would you know how to make a tablet
that doesn't have that burst effect, not whether or
not Amneal knew what they were doing.
THE WITNESS: You would know for the reasons I've
described. You could make a formulation which is
controlled such that it doesn't have an immediate
release burst effect for the reasons I've described.
You could use a formulation, say, which has

52

controlling membrane, that would overcome the burst
effect.
Tr. 383:14-386:16.
Moreover, Dr. Davies could provide little guidance, beyond
the dissolution profile, 28 to describe the Defendants’ supposed
immediate release formulation.
Q: And so if I'm a manufacturer and I want to make a
matrix tablet that doesn't contain an immediate
release formulation of guaifenesin, in your opinion,
how big can -- how much dissolution can I have of
guaifenesin in the first hour without someone like you
coming and arguing that I have an immediate release
formulation of guaifenesin?
A: I think -- I think it would be that you would not
be able to make a matrix tablet to meet this
dissolution profile. Given the dissolution profile and
the PK data, you'd have to use some kind of coating to
stop that burst effect based on the formulations.

28

Dr. Davies testified that the dissolution and PK data of DRL’s
tablet support his Raman analysis conclusions. Tr. 118-19.
Dissolution testing shows that in the first hour,
guaifenesin in DRL’s tablet is released, and that
e
rate slows significantly such that the guaifenesin continues
releasing for 12 hours. Id. Summarizing his findings, Dr.
Davies testified that the IR portion of DRL’s products
contributes to the
of guaifenesin released within the first
hour, while the SR
tion releases guaifenesin after that time.
Id. Dr. Davies ALSO testified that the dissolution and PK data
of Amneal’s tablet support his analysis conclusions that there
are two portions. Id. at 191-93. Dissolution testing shows
that in the first hour,
of the guaifenesin in DRL’s
tablet is released, and
he release rate slows
significantly such that the guaifenesin continues releasing for
18 hours. Id. at 117:12. Dr. Davies testified that this
evidence, in addition to Amneal’s own in vitro dissolution
studies and in vivo pharmacokinetic studies, show that Amneal’s
products have a biphasic release profile. Id. at 116-17.
53

Tr. 387:9-19.
Essentially, Dr. Davies labeled guaifenesin on the surface
(and maybe a little bit below) as an immediate release
formulation.

He opined that a POSA would know “straightaway”

that guaifenesin on the surface is an immediate release
formulation.

Tr. 263:23-25.

In other words, Dr. Davies’s

opinion boiled down to this simple proposition: if there is any
guaifenesin on the outside of the tablet, there is, by
definition, an immediate release formulation present.

Thus, in

any non core-coated tablet, there will seemingly always be at
least two formulations.

The Court is unconvinced for the

reasons the Defendants’ experts articulated as set forth above.
3.

Defendants’ Manufacturing Processes Confirm a
Single Formulation

Each Defendant introduced evidence of its manufacturing
process to show that its process produces single formulation
tablets.

Specifically, Drs. Gemeinhart and Brittain testified

that Defendants’ manufacturing processes start with a single
formulation and end with single formulation matrix tablets.

As

Defendants correctly argue, Reckitt failed to identify any step
in the process that could result in the formulation of two
distinct formulations. 29

29

Reckitt argues that this Court should ignore evidence about
Defendants’ manufacturing processes because that would
impermissibly import process limitations into the claims. This
54

a.

Amneal’s Manufacturing Process

Dr. Gemeinhart described Amneal’s process as mixing
everything together, blending it to uniformity, and then
compressing it into a tablet.

Tr. 718:2-8.

First, guaifenesin

granules are produced through a wet-granulation process, in
which water is added to a guaifenesin and povidone premix and
mixed to create a homogeneous blend of ingredients.
718:10–720:22.

Id. at

Following wet-granulation, the granules are

dried and then re-milled to obtain a uniform granule.
721:4-13.

Id. at

The next step is to effectively mix the rest of the

ingredients 30 together in a particular “V blender” and then blend
to obtain a uniform mixture.

Id. at 721:19–722:22.

Finally,

the uniform blend undergoes compression to create a tablet.
at 725:20-24.

Id.

Dr. Gemeinhart testified that this manufacturing

process creates a one formulation tablet.

Id. at 725:25-726:4.

Dr. Gemeinhart also discussed the blend uniformity and
content uniformity testing that Amneal conducts during its
manufacturing process.

Amneal ensures blend uniformity by

taking ten samples from the V-blender and testing for
guaifenesin content, which Dr. Gemeinhart persuasively explained

Court disagrees. Such evidence goes to whether or not the
products produced contain two formulations.
30

The exception is magnesium stearate, which is added after
blending because if it is mixed too long its properties can be
altered. Tr. 724:11-22.
55

is representative of the uniformity of all the ingredients in
the mixture.

Id. at 726:9–730:7.

Dr. Gemeinhart testified that

Amneal’s blend uniformity data shows that its products do not
undergo segregation or separation.

Id. at 733:2-19. Dr.

Gemeinhart testified that this tells a POSA “that you have a
uniform – and in this case . . . matrix tablet, that you will
have that type of tablet every time, or nearly every time.” Id.
at 733:24-734:1.
Again, although Reckitt argues that Amneal’s blend
uniformity testing does not prove the final product is uniform,
because the testing occurs before the mixture is compressed into
tablets, the Court, nonetheless, finds such testing to be
probative.

P. Res. Post-Trial Br. 8.

Reckitt has put forth no

evidence that the compression process will destroy the blend
uniformity.

Additionally, while Plaintiff has put indirect

evidence contesting the adequacy of the blend uniformity
testing, the Court finds Dr. Gemeinhart’s testimony far more
persuasive.

Dr. Gemeinhart’s testimony regarding the blend

uniformity data supports Amneal’s position that Amneal’s
manufacturing process produces a single and uniform formulation
in the final product. 31

31

As further evidence that
produces a uniform tablet,
optical microscopy that he
scalpel to cut the tablets

Amneal’s manufacturing process
Dr. Rogers testified about the
performed. First, Dr. Rogers used a
in half and then took pictures at
56

b.

DRL’s Manufacturing Process

Defendant DRL put forth evidence regarding its
manufacturing process to prove its ANDA products are singleformulation matrix tablets.

Tr. 556:24–558:3.

As Reckitt put forth

no evidence to refute this manufacturing process, the Court is
persuaded by Dr. Brittain’s testimony.

various magnifications of the outside of the pill as well as a
cross-section of the pill. Id. at 902:24–903:8. Dr. Rogers
testified that these images do not show the chemical composition
of the tablet, but do illustrate a uniform mix of the blue dye
and the white ingredients. Id. at 903:12-16. Additionally, he
stated that images DTX-044-2 (depicts exterior) and DTX-044-5
(depicts interior) show the same uniform mix of blue and white
in the cross section of the tablet as in the exterior, and that
no aggregation or segregation is visually detectable. Id. at
903:21–904:3. However, on cross examination Dr. Rogers agreed
that the test did not function as a chemical identification and
that he could only see color. Id. at 970:7-25. Additionally,
the test did not give information on the distribution of the
molecular components. Id. at 971:1-4. As such, the Court does
not find Dr. Rogers’s optical microscopy testing to be
particularly useful.

57

The Court credits Dr. Brittain’s testimony that
“the entire manufacturing process is geared towards yielding
dosage forms that are uniform.
forms from uniform blends.”

You can only make uniform dosage

Tr. 594:24–595:3.

Additionally,

Dr. Brittain persuasively testified that it is not possible for
the compression step to “somehow transform the guaifenesin into
a layer around the surface that doesn’t contain the ingredients
that were intimately mixed with the guaifenesin in the
granules.”

Id. at 595:8-11.

In sum, DRL’s evidence, unrebutted

58

by Reckitt, supports a finding that DRL’s manufacturing process
produces a single formulation. 32
C.

Conclusion – No Literal Infringement

For the foregoing reasons, this Court finds that
Defendants’ products are a single formulation matrix and do not
contain two distinct formulations.

Accordingly, Reckitt has

failed to prove by a preponderance of the evidence that every
limitation of the asserted claims was literally met by
Defendants’ ANDA products.
VI.

Infringement Under Doctrine of Equivalents
Even if the Defendants’ ANDA products do not literally

infringe, Reckitt argues that they infringe under the doctrine
of equivalents.

Under the doctrine of equivalents, a device or

product “that does not literally infringe upon the express terms
of a patent claim may nonetheless be found to infringe if there
is ‘equivalence’ between the elements of the accused product or
process and the claimed element of the patented invention.”
Warner-Jenkinson Co. v. Hilton Davies Chem. Co., 520 U.S. 17, 21
(1997).

A patentee must establish “equivalency on a limitation-

by-limitation basis” by “particularized testimony and linking
argument” as to the insubstantiality of the differences between

32

The Court need not reach Reckitt’s reserved objection on the
issue of DRL’s content uniformity tests.
59

the claimed invention and the accused device or process.

Texas

Instruments Inc. v. Cypress Semiconductor Corp., 90 F.3d 1558,
1566 (Fed. Cir. 1996).

If a theory of equivalence would vitiate

a particular claim element, then non-infringement is warranted.
Stated differently, if the alleged equivalent product is so
inconsistent with the claimed element that a finding of
equivalents would essentially eliminate the element as a
meaningful limitation of the invention, then non-infringement is
warranted.

Akzo Nobel Coatings, Inc. v. Dow Chemical Co., 811

F.3d 1334, 1342 (Fed. Cir. 2016).
Although two different tests have developed for
establishing equivalency, the function-way-result and
insubstantial differences tests, the Supreme Court has accepted
both as probative of the essential inquiry.
520 U.S. at 40.

Warner-Jenkinson,

The function-way result test often suffices to

show the substantiality or insubstantiality of the differences.
Akzo, 811 F.3d at 1342.

A device or process infringes if it

performs “substantially the same function in substantially the
same way to obtain the same result.”

Graver Tank & Mfg. Co. v.

Linde Air Prod. Co., 339 U.S. 605, 608 (1950).

Relatedly, a

claim element is deemed to be equivalently present in an accused
product if “‘insubstantial differences’ distinguish the missing
claim element from the corresponding aspects of the accused

60

device.”

Sage Prod., Inc. v. Devon Indus., Inc., 126 F.3d 1420,

1423 (Fed. Cir. 1997).
Relevant to this case, the Federal Circuit has explained
that “bioequivalency and equivalent infringement are different
inquiries.”

Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1298

(Fed. Cir. 2009).

Therefore, under the doctrine of equivalents

bioequivalence does not necessitate infringement by equivalence.
Watson, 430 F. App'x 871, 878 (Fed. Cir. 2011).
Reckitt contends that Defendants’ products infringe under
the doctrine of equivalents because they contain two “portions”
or “quantities” that perform substantially the same function, in
substantially the same way, with substantially the same results
as the IR and SR “portions” or “quantities” of the asserted
claims.

P. Post-Trial Br. 35.

Reckitt states that the

pertinent question is:
Does the surface of Defendants’ tablets, which are
covered almost entirely with guaifenesin and very
small amount of polymer, perform substantially the
same function, in substantially the same way, with
substantially the same results as the first immediate
release portion and/or quantity of the asserted
claims?
Id. As there is not much disagreement between the parties
over the “function” and “result” analysis, this Court will
focus on the “way” the Defendants’ products operate.
Dr. Davies testified that the Defendants have a structure
that is similar to the core-coated tablet that is a preferred
61

embodiment in the Patents-in-Suit.

Tr. 235:13-15; see also ’821

Patent col. 12:46-56; ’032 Patent col. 17:45-54. 33

According to

Dr. Davies, there is no difference between the coating layer of
a core-coated tablet and the regions of the Defendants’ products
that he identified as the immediate release portions.

Dr.

Davies acknowledged, however, that unlike the core-coated tablet
embodied in the Patents-in-Suit, the so-called immediate release
layer in Defendants’ is “not 100 percent covering the outside of
the tablet.”

Tr. 237:3-8.

Summarized below is Dr. Davies’s

opinion on equivalents:
Q: Okay. Dr. Davies, focusing on the immediate release
coating layer of a core coated tablet, one in which
the core and the outer layer are manufactured
separately and separately applied to produce the
product, what is the function of that outer coating
layer, this one right here?
A: The function is to obtain a burst of the immediate
release of the drug.
Q: And what is the way in which this coating layer
performs that function?

33

The Patents provide “The bi-layer tablet may be manufactured
according to any method known to those of skill in the art. The
resulting tablet comprises the two portions compressed against
one another so that the face of each portion is exposed as
either the top or bottom of the tablet, or the resulting tablet
may comprise the sustained release portion in the center coated
by the immediate release portion so that only the immediate
release portion is exposed. In a preferred embodiment, a bilayer tablet comprises the two portions compressed against one
another so that the face of each portion is exposed.” See ’821
Patent col. 12:46-56; ’032 Patent col. 17:45-54.
62

A: The way in which it performs the function is that
it -- guaifenesin present in other excipients other
than the rate-controlling polymer, such that it will
be an immediate release form and be released. It's
also the fact that it's configured on the outside of
the tablet, such that it's the first part of the
tablet that is in contact with the gastric juice
allowing immediate release of the drug.
Q: And what is the result obtained through such an
immediate release coating layer, separately applied
coating layer?
A: The result is the contribution to the Cmax which
will be equivalent to that in Mucinex® or in immediate
release formulation.
Q: Is this also a fair recitation of the function, way
and result of the first portion, first quantity
elements of the asserted claims in the case?
A: I believe so.
. . .
Q: So, now the regions of defendants' products that
you identified as the first portion or first quantity,
do they perform the same function as that which you
identified for an IR coating of a core coated tablet?
A: Yes, they do, as we see from the diagram that they
provide an immediate or rapid release of guaifenesin.
Q: And why do you say that they provide a rapid
release of guaifenesin?
A: Because we know that they do based on dissolution
studies and the like, and they're also, as I've said,
they're all in the surface in a form, in immediate
release form, that they are present on the surface, on
the outer surface so they are the first, that's the
first part of the tablet which is exposed to the
gastric juice.
Tr. 239:5-241:2

63

As further support for his testimony, Dr. Davies
highlighted a passage from Amneal’s ANDA that provides:
[its] composition is very similar [to Mucinex®], however
minor differences between the proposed formulation and the
RLD [Mucinex®] are considered irrelevant in the context of
having a potential effect with respect to therapeutic
equivalence or stability. This is based upon the noted
similarities between the two products, both in terms of
dosage form and dosage form design.
PTX-63 at 0262. In Dr. Davies’s opinion, this statement also
applies to DRL’s products.

Tr. 242:11-13.

Plaintiff next cites to statements made by Defendants’ own
experts.

Dr. Rogers testified that the way an IR portion would

rapidly release could be achieved by not inhibiting guaifenesin
with polymer.

Tr. 973:1-4.

Additionally, Plaintiff cites to

several statements that it claims show Defendants’ experts
agreed that guaifenesin on the surface of Defendants’ tablets
rapidly releases because it is uninhibited by

polymers.

Tr. 640:5-641:4; 660:19-24; 668:10-16; 670:14-20 (Dr. Brittain);
Tr. 812:4-25; 875:5-9 (Dr. Gemeinhart).

Finally, Plaintiff

cites to statements by Defendants’ experts that it claims
undermine Defendants’ argument that their products release
guaifenesin via a single mechanism.

Dr. Gemeinhart testified

that once the gel layer forms, the drug is released by diffusion
through the layer; however, “instantaneously upon ingestion,”
the guaifenesin molecules at the surface are not diffusing
through any polymer gel.

Tr. 863:1-8.
64

Thus, Reckitt argues

that the IR regions of guaifenesin identified by Dr. Davies in
Defendants’ products perform substantially the same function, in
substantially the same way, to provide substantially the same
result as the immediate release layer of the core-coated tablet
embodiment of the ’032 and ’821 Patents.
Defendants counter that “Reckitt’s simplistic suggestion
that Defendants’ matrix tablets operate in the same way as a
true immediate release formulation because both permit the
release of guaifenesin when wetted with gastric juice ignores
the details of this process” which are necessary in an
equivalents analysis.

Def. Resp. post-Trial Br. at 35.

The

Court agrees.
The evidence at trial demonstrated that, in a core-coated
tablet, the immediate release formulation on the outside is
specifically designed to disintegrate quickly.
see also Tr. 819:9-10.

Tr. 600:15-25;

In contrast, Defendants’ matrix tablets

do not have a “distinct formulation” that is designed to
disintegrate and rapidly release the drug.

Both Drs. Gemeinhart

and Brittain persuasively explained that the sustained drug
release in Defendants’ matrix tablets, including the about 20%
guaifenesin released during the first hour, is a function of the
degree to which the polymer matrix continuously hydrates and
gels.

As Dr. Brittain credibly testified, the polymer matrix

begins to hydrate and gel as soon as the tablet is wetted in the
65

mouth or the stomach but, initially, the gel layer is simply not
fully formed and not very efficient. Tr. 658-659.

As the gel

layer continues to hydrate over time, it creates a physical
barrier through which the drug substance must diffuse, resulting
in a slower rate of release. Id.
This is simply a continuous process, and there are no
intermediate stages that you can say correspond to a
different type of drug release. The drug is always
being released through the same mechanism. It’s just
that the size of the barrier is changing.
Tr. 594:10-14; see also Tr. 590:4-594:13; 610:10-21.
Using a schematic, DTX 31-37 (below), Dr. Gemeinhart
also credibly explained the process:

(DTX 31-37)
Q: What does this show, Dr. Gemeinhart?
A: So this is the schema for what really is described
as a continuous or smooth and continuous release of
the guaifenesin, the API from the tablets, that you
start with that matrix. It's a single matrix at that
point, that as you enter this into the fluid, and
you'll begin several processes all at once, and that
the rates of each of those are going to be based on
the chemistry of those individual pieces.
66

So you will have molecules of the API dissolving,
based on their dissolution and dissolution rate, and
you will have the polymer swelling, interacting and
forming that gel. It's those -- at every single time
point within here. You will have molecules diffusing
and that it goes through a process, that gel network
will form and the gelation is really the description
of what's happening.
. . .
If you look at this schematic depiction, the
description is the molecules are coming off, the gel
is forming and then you have the gel eroding.
Tr. 734:7-735:10. 34
In sum, the Court finds that the initial rapid dissolution
of guaifenesin from the surface of Defendants’ tablets, as a
result of hydration, which is a continuing release, is not
equivalent to an immediate release formulation.
substantially different.

These are

A true immediate release formulation

releases everything at once.

That some guaifenesin molecules

are on the surface of Defendants’ tablets and release as a
result of hydration does not mean that Defendants’ products
function the same way.

At best, Dr. Davies testified that the

guaifenesin on the surface rapidly releases because it is
uninhibited by

polymers.

34

This, however, is not the

For the reasons articulated by Defendants, Def. Supp. PostTrial Br. at 13-14 [Docket No. 203], the Court does not agree
with Reckitt’s argument that Dr. Gemeinhart admitted that any
product that perform an immediate function does so in the same
way.
67

“particularized testimony” that is needed to show that the
incidental release of guaifenesin is the same as an immediate
release layer.

A finding of equivalents under this theory would

vitiate the claims’ requirement that there be two distinct
formulations.

Accordingly, Reckitt has not met its burden of

proving infringement under the doctrine of equivalents.
VII. Conclusion
For the foregoing reasons, the Court finds that Defendants’
ANDA products will not infringe the ’032 and ’821 Patents.
Accordingly, the Court enters judgment of non-infringement. 35

An

appropriate Order will issue herewith.

s/Renée Marie Bumb
RENÉE MARIE BUMB
UNITED STATES DISTRICT JUDGE

35

The Court declines to exercise jurisdiction over the counter
claims alleging invalidity of the Patents-in-Suit. AstraZeneca
LP v. Breath Ltd., 542 Fed. Appx. 971, 981 (Fed. Cir. 2013).
68